There is renewed and continuing focus on treatments for infections and diseases that include, but are not limited to, malaria, yellow fever, dengue fever, caused by mosquito bites; dysentery caused by bacteria and parasites; Lyme disease and babesiosis, caused by ticks. Often there is not a satisfactory prophylaxis treatment or, in the case of malaria, antimalarial treatments with quinine and other synthetic drugs have resulted in drug resistant strains of malaria which can result in severe adverse outcomes, such as increased mortality, morbidity and medical care costs for patients suffering from common infections, once treatable.
Malaria has four types that can infect humans. Of the four types of malaria, the most life-threatening type is Plasmodium falciparum, known to be the most lethal form of the plasmodium parasite, causing the greatest number of malaria infections and deaths. Often called jungle fever or swamp fever, malaria is characterized by cycles of chills, fever, and sweating, caused by the parasitic infection of red blood cells by the protozoan parasite Plasmodium which is transmitted by the bite of an infected vector for human malarial parasite, a female Anopheles mosquito.
The other three types of malaria which include vivax, malariae, and ovale, are generally less serious and are not life-threatening but need to be treated, as their untreated progress can cause a host of health problems.
To date, there is no absolute cure for malaria. Early diagnosis can lead to alleviation of malaria, and prevention remains more effective than treatment. Anti-malarial medication can and should be taken preventively by native populations and travelers in affected regions, such as the tropics and sub-Saharan Africa.
Anti-malarial drugs are available that treat malaria effectively, but there remains the problem of incorrect dosages by self-administering patients, inaccurate combining of ACTs (artemisinin combination therapy) which leads to potential mono-therapeutic treatment with artemisinin and results in highly-resistant strains of malaria, and the lack of adequate delivery systems for children, all of which causes the pattern of repetitive disease to continue.
Another problem is that many of the current ACTs contain some form of quinine, which has long been determined to have serious side effects, especially in children.
Yellow fever is a viral infection and is carried by female mosquitoes of two species (Aedes and Haemogogus). The “yellow” in the name refers to the jaundice that affects some patients. Mosquitoes pass yellow fever to humans through a small amount of saliva when they bite. The species of mosquito that carry yellow fever are native to sub-Saharan Africa and South America.
Yellow fever can cause flu-like symptoms, fever, headache, muscle pain, chills, nausea, vomiting, yellowing of both the skin and the whites of the eyes, and can cause death. Vaccination is the best way to prevent yellow fever. However, people with compromised immune systems, elderly individuals, and women who may be pregnant or nursing should not receive the vaccine.
There is presently no specific treatment for yellow fever, only supportive care to treat dehydration and fever. Associated bacterial infections can be treated with antibiotics. Supportive care may improve outcomes for seriously ill patients, but it is rarely available in poorer areas.
Prompt detection of yellow fever and rapid response through emergency vaccination campaigns are essential for controlling outbreaks. However, underreporting is a concern and the true number of cases is estimated to be 10 to 250 times what is now being reported. The World Health Organization (WHO) recommends that every at-risk country have at least one national laboratory where basic yellow fever blood tests can be performed. Due to the severe threat of epidemic, and the resultant loss of life on a large scale, one confirmed case of yellow fever in an unvaccinated population should be considered an outbreak, and a confirmed case in any context must be fully investigated, particularly in any area where most of the population has been vaccinated.
Dengue fever is a viral infection transmitted by the bite of an infected mosquito. Mosquitoes can pick up the dengue virus then carry the virus in their own blood, and spread it when they bite humans. The Center for Disease Control and Prevention reports that with more than one-third of the world's population living in areas at risk for transmission, dengue infection is a leading cause of illness and death in the tropics and subtropics. As many as 100 million people are infected yearly. The symptoms of dengue fever resemble symptoms of influenza (flu) and can include fever, severe headache, severe pain behind the eyes, joint pain, muscle and/or bone pain, rash and the like. See for example, Dengue Page, CDC Centers for Disease Control and Prevention, CDC 24/7: http://www.cdc.gov/dengue, Sep. 27, 2012.
Dengue hemorrhagic fever (DHR) is characterized by a fever that lasts from 2 to 7 days, with general signs and symptoms consistent with dengue fever. When the fever declines, hemorrhagic manifestations and low platelet count accompanies other symptoms. There is no specific medication for treatment of a dengue infection. Analgesics, such as acetaminophen, are recommended for pain relief. Aspirin and aspirin-containing drugs should not be taken because aspirin would increase the risk for severe bleeding and hemorrhage.
Dysentery is an intestinal inflammation, especially in the colon, that can lead to severe diarrhea with mucus or blood in the feces. There are two main types of dysentery. Bacillary dysentery is caused by Shigella, a bacterium that secretes substances known as cytotoxins, which kill and damage intestinal tissue on contact. Amoebic dysentery (amoebiasis) is caused by Entamoeba histolytica, a type of amoeba that reaches the large intestine after entering orally, through ingestion of contaminated food or water, or oral contact with contaminated objects or hands.
Other symptoms that accompany frequent watery stools include abdominal pain, fever and chills, nausea and vomiting. Treatment can include rehydration therapy, administration of antibiotics and amoebicidal drugs. Prevention can include good hygiene, taking measures to reduce risk of infection by regularly washing hands after going to the toilet and before preparing or eating food, drinking water from reliable sources and using purified water to clean your teeth.
Lyme disease is a bacterial infection transmitted by a tick. Lyme disease was first recognized around 1975, after an unusually large number of children were being diagnosed with juvenile rheumatoid arthritis in Lyme, Conn. (USA) and two neighboring towns. Tiny deer ticks infected with the bacterium Borrelia burgdorferi, were found to be responsible for the outbreak of arthritis in Lyme.
Not every bite from a deer tick causes Lyme disease. It is more likely to occur if the tick stays attached to an individual's skin for 36 hours or more. Cases have been reported in nearly all states, and the disease is also on the rise in large areas of Asia and Europe.
Lyme disease can be transmitted through a bite from ticks infected with Borrelia burgdorferi. In the early stages of Lyme disease, there are flu-like symptoms that can include a stiff neck, chills, fever, swollen lymph nodes, headaches, fatigue, muscle aches and joint pain. There may also be a large, expanding skin rash around the area of the tick bite. Treatment includes antibiotics, such as doxycycline or amoxicillin. The sooner such therapy is begun following infection, the quicker and more complete the recovery. Prolonged antibiotic use may have serious side effects.
In the late stage of the disease, in addition to causing arthritis, Lyme disease can also cause heart, brain and nerve problems.
Babesiosis is a malaria-like illness caused by a protozoan parasite (Babesia microti in the United States and other members of the Babesia genus in Europe) that invades red blood cells, and is primarily transmitted by the deer tick Ixodes scapularis and possibly other related Ixodid ticks.
In Europe, reported fatal cases of babesiosis have occurred mostly in patients whose spleens have been removed, rendering them more vulnerable to infection. The offending parasites in these cases have been either B. divergens or B. major, to which humans (with spleens intact) are thought to be naturally resistant. In the U.S., reported fatal cases have occurred in patients both with and without spleens; B. microti may be a more virulent agent to which humans are not naturally resistant. However, while many in the U.S. who are exposed to the parasite do suffer severe symptoms, fatalities generally occur in elderly patients with compromised immune systems. The heightened risk is in misdiagnosis; since the illness presents like a severe case of influenza, many of those infected do not seek treatment. Unlike Lyme disease, babesiosis does not always present with a tell-tale rash, making it more difficult to suspect. There is a 20% mortality rate for those who are severely infected and do not receive treatment.
Babesiosis cases have been on the rise in the U.S. since the first human case was recognized on Nantucket Island (off the coast of Massachusetts) in 1968. Due to climate changes, the expanding domain of ticks that carry the parasite, and greater human and pet interaction with areas containing the ticks, babesiosis now presents a real danger to those residing and venturing into areas of contamination. The deer (black-legged) tick in the Northeast and upper Midwest, and the Western black-legged tick on the Pacific coast are the primary carriers. A majority of reported cases occur during the summer months along the immediate coast and off-shore islands of the Northeast, but the ticks have now migrated to areas of the Mid-Atlantic and further South.
The symptoms of babesiosis normally begin about a week after a tick bite with a gradual onset of malaise, anorexia and fatigue. This is followed several days later by high fever, drenching sweats, muscle pain and headaches. As with malaria, these symptoms can continue over a protracted period or can abate, then recur. Diagnosis can involve examining blood smears and recognizing the characteristic “ring” form taken by the Babesia parasite within the red blood cells of the patient. Recommended treatment has included a seven-day course of oral quinine plus clindamycin under the careful supervision of a physician. Both of these remedies have been used on malaria as well, now to be supplanted by the more preferable ACTs. Since quinine has known negative side effects, and can be harmful to both children and pregnant women, a natural ACT with no known side effects should be the preferred course of treatment. Without it, fatigue, malaise and a low grade fever may persist for weeks or months after quinine and clindamycin treatment has been completed.
Progressive multifocal leukoencephalopathy (PML) is a disease of the white matter of the brain, caused by a virus infection that targets cells that make myelin (the material that insulates neurons). PML is a demyelinating disease, in which the myelin sheath covering the axons of nerve cells is gradually destroyed, impairing the transmission of nerve impulses. It affects the subcortical white matter, particularly that of the parietal and occipital lobes. PML is similar to another demyelinating disease, multiple sclerosis, but progresses much more quickly.
A certain strain of polyomavirus (referred to as John-Cunningham Virus, JCV) is carried by a majority of people and is harmless except among those with lowered immune defenses. It seems that by lowering the immune reaction, the JCV virus is reactivated and is causing demyelinization leading to PML. The PML disease is rare and occurs in patients undergoing chronic corticosteroid or immunosuppressive therapy for organ transplant, or individuals with cancer (such as Hodgkin's disease or lymphoma). Individuals with autoimmune conditions such as multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosis (some of whom are treated with biological therapies that allow JCV reactivation) are at risk for PML as well.
PML is most common among individuals with human immunodeficiency virus (HIV-1) infection; as well as acquired immune deficiency syndrome (AIDS). Studies estimate that prior to effective antiretroviral therapy, as many as 5 percent of persons infected with HIV-1 eventually develop PML that is an AIDS-defining illness. However, current HIV therapy using antiretroviral drugs (ART), which effectively restores immune system function, allows as many as half of all HIV-PML patients to survive, although they may sometimes have an inflammatory reaction in the regions of the brain affected by PML A diagnosis of PML can be made following brain biopsy or by combining observations of a progressive course of the disease, consistent white matter lesions visible on a magnetic resonance imaging (MRI) scan, and the detection of the JCV in spinal fluid.
Symptoms can include weakness or paralysis, vision loss, impaired speech, and cognitive deterioration, the most prominent symptoms can include clumsiness; progressive weakness; and visual, speech, and personality changes. In addition, the lesions affecting the parietal and occipital lobes can lead to a phenomenon known as alien hand syndrome. The symptoms of PML are diverse, since they are related to the location and amount of damage in the brain, and may evolve over the course of several weeks to months. The progression of deficits leads to life-threatening disability and (frequently) death.
PML can be diagnosed by testing for JCV DNA (deoxyribonucleic acid) in cerebrospinal fluid or in a brain biopsy specimen. Characteristic evidence of the damage caused by PML in the brain can also be detected on magnetic resonance imaging (MRI) images, which classically show multifocal nonenhancing lesions without mass effect. The most common area of involvement is the cortical white matter, but the brainstem and cerebellum may also be involved.
There is no known cure for PML. In some cases, the disease slows or stops if the patient's immune system improves; some AIDS patients with PML have been able to survive for several years, with the advent of highly active antiretroviral therapy (HAART). AIDS patients who start HAART after being diagnosed with PML tend to have a slightly longer survival time than patients who were already on HAART and then develop PML. A rare complication of effective HAART is immune reconstitution inflammatory syndrome (IRIS), in which increased immune system activity actually increases the damage caused by the infection; although IRIS is often manageable with other types of drugs, it is extremely dangerous if it occurs in PML.
Other antiviral agents that have been studied as possible treatments for PML include cidofovir and interleukin-2, but this research is still preliminary. Cytarabine (also known as ARA-C), a chemotherapy drug used to treat certain cancers, has been prescribed on an experimental basis for a small number of non-AIDS PML patients. It is reported to have stabilized the neurological condition of a minority of these patients. One patient regained some cognitive function lost as a result of PML.
In June 2010, the first case report appeared of a PML patient being successfully treated with mefloquine. Mefloquine is an antimalarial drug that can also act against the JCV. Administration of mefloquine seemed to eliminate the virus from the patient's body and prevented further neurological deterioration. It is our thought and hope, that with a study conducted by the H. Lee Moffitt Cancer Center & Research Institute in Tampa Fla. using our ACT, which is devoid of the potentially damaging quinine and its derivatives, but is similar in action to mefloquine against malaria, may eventually prove to be an effective agent against the JCV, and subsequently lead to the successful safe treatment of PML patients. See for example, T E Gofton, A Al-Khotani, B O'Farrell, et al. Mefloquine in the treatment of progressive multifocal leukoencephalopathy. Journal Neurolology and Neurosurgery Psychiatry (2010). 82(4):452-5
Helicobacter pylori (HP) was first discovered in the stomachs of patients with gastritis and stomach ulcers by Dr Barry J. Marshall and Dr J. Robin Warren, both of Australia. In 1982, conventional thinking held that bacteria could not live in the human stomach, due to the high levels of acid present there, similar in strength to the acid found in an auto battery. Marshall and Warren altered the course of medicine with their discovery and for that, were awarded the 2005 Nobel Prize for Medicine and Physiology.
HP is a corkscrew-shaped, Gram-negative bacterium which is present in the stomach lining of approximately 3 billion people worldwide, and is the most common bacterial infection found in humans. Many of those carrying the bacterium have few or no symptoms, with the exception of inflammation of the stomach lining, a condition which is called “gastritis.” Gastritis is the underlying condition which can eventually cause ulcers and other digestive ailments. An HP infection maintained for 20-30 years can lead to cancer of the stomach. For this reason, the World Health Organization's International Agency for Research into Cancer has classified HP as a “Class I Carcinogen,” likening its danger to the digestive system to that of cigarette smoking to the lungs and respiratory tract.
The diseases are associated with HP can include duodenal ulcers, gastric (stomach) ulcers, stomach cancer, and non-ulcer dyspepsia. Diagnostic testing for HP can include breath tests, blood tests, endoscopies, and biopsies. Common treatment for HP can be heavy dosing of antibiotics, given in combinations of two to four substances, commonly through a Proton Pump Inhibitor. The treatment can be expensive, debilitating, and unsuccessful. Since HP has developed resistance to many commonly used antibiotics, new treatments must be sought out and identified.
Artemisinin Combination Therapy (ACT) has been an alternative treatment which shows great promise in its ability to act as a broad-based antibiotic and anti-parasitic, especially when dealing with infections that are rising through contamination by fecal matter, as HP is known to be. ACTs are less debilitating for the patient, and have no known side effects as many of the currently prescribed antibiotics have. See for example, Goswami S, B. R. (Epub 2012 Jun. 11). Anti-Helicobacter pylori potential of artemisinin and its derivatives. Antimicrobial Agents and Chemotherapy., 56(9):4594-607.
Colitis is a disease caused by inflammation of the large intestine, leading to symptoms which can include frequent diarrhea. Diarrheal diseases are among the leading causes of morbidity and mortality in children worldwide, causing 1 billion episodes of illness and 3-5 million deaths annually. In the United States, approximately 20-35 million episodes of diarrhea occur each year in the 16.5 million children who are younger than 5 years, resulting in 300-400 deaths.
Inflammatory bowel disease (IBD) is a generic term used to describe idiopathic disorders that are associated with gastrointestinal (GI) inflammation which can include Crohn's disease (CD), Ulcerative colitis (UC), and Indeterminate colitis. Colitis can have many different causes, which can include infections, including those caused by a virus, parasite, and food poisoning due to bacteria, inflammatory disorders (ulcerative colitis and Crohn's disease), lack of blood flow (including ischemic colitis and HSP), past radiation to the large intestine, Necrotizing enterocolitis (NEC), Allergic colitis, Pseudomembranous colitis, and Colitis secondary to immune deficiency disorder. IBD symptoms can include abdominal pain and bloating that is intermittent and unpredictable, bloody stools, chills, constant urge to have a bowel movement, dehydration, frequent diarrhea, and persistent fever.
The onset of IBD commonly can occur during adolescence and young adulthood. The risk of IBD in family members of an affected individual is approximately 7-22%; a child's risk of acquiring the disease is up to 60%, and this risk is higher if both parents have the disease. The prevalence of UC in the United States is 100-200 per 100,000 population. The incidence of CD is approximately 3-4 per 100,000 population, and the prevalence is approximately 30-100 per 100,000 population.
NEC is a disease of newborns, with low- and very low-birth-weight preterm infants being particularly susceptible. NEC affects approximately 1-5% of patients admitted to neonatal intensive care units (ICUs) and may occur in approximately 2-5% of infants with birth weights lower than 1500 g (approximately 3 lbs. 5 oz.). Allergic colitis is the most common form of colitis during the first year of life.
IBD is generally diagnosed in children aged 5-16 years. It has a bimodal distribution, with an early onset at age 15-25 years and a second smaller peak at age 50-80 years. The prevalence of IBD is increased among Jewish people of European Ashkenazi descent. A positive family history is the most consistent risk factor for children with IBD. HSP is common in Caucasians. Food-allergic colitis is believed to be present in approximately 0.5% of all infants.
Complications of IBD can include bleeding from the bowels, perforation in the colon, toxic mega colon, and ulceration of the colon. The most serious acute complication of UC is toxic mega colon with the risk of perforation. The risk of colon cancer increases after 8-10 years of having UC. The complications of CD tend to increase with time and include bowel strictures, fistulas, abscess, and intestinal obstruction. After surgery, patients may develop short bowel syndrome and mal-absorption.
References to colitis can include:    Lee I A, H. Y. (2010). Berberine ameliorates TNBS-induced colitis by inhibiting lipid peroxidation, enterobacterial growth and NF-κB activation. European Journal of Pharmacology, 648(1-3):162-70;    Zhang M, L. Y. (2011). Evidence for the complementary and synergistic effects of the three-alkaloid combination regimen containing berberine, hypaconitine and skimmianine on the ulcerative colitis rats induced by trinitrobenzene-sulfonic acid. European Journal of Pharmacology, 651(1-3): 187-96;    Yan F, W. L. (2012). Berberine promotes recovery of colitis and inhibits inflammatory responses in colonic macrophages and epithelial cells in DSS-treated mice. American journal of physiology. Gastrointestinal and liver physiology, 302(5):G504-14;    Li G H, W. D. (2012). Berberine inhibits acute radiation intestinal syndrome in human with abdomen radiotherapy. Medical Oncology, 27(3):919-25; and    Kawashima K, N. A. (2004). Pharmacological properties of traditional medicine (XXIX): effect of Hange-shashin-to and the combinations of its herbal constituents on rat experimental colitis. Biological and pharmaceutical bulletin, 1599-603.
Natural substances, such as artemisinin, as well as derivatives and modifications thereof, have been used for many years as natural medications for treating infections and diseases caused by bacteria, viruses and parasites.
According to N. J. White in “Assessment of the pharmacodynamic properties of antimalarial drugs in vivo” Antimicrobial. Agents Chemotherapy. 41 (7): 1413-1422 (July 1997), artemisinin, and its derivatives are a group of herbal compounds that possess the most rapid action of all current drugs against falciparum malaria. Treatments containing an artemisinin derivative (artemisinin-combination therapies, ACTs) are now standard treatment worldwide for falciparum malaria. The starting compound artemisinin is isolated from the plant Artemisia annua, an herb described in Chinese traditional medicine.
For many years after the discovery, access to the purified drug and the plant it was extracted from were restricted by the Chinese government. It was not until the later 1970s and early 80s that news of the discovery reached scientists outside China. In 2006, after artemisinin had become the treatment of choice for malaria, the World Health Organization (WHO) called for an immediate halt to single-drug artemisinin preparations in favor of medications that combine artemisinin with another malaria drug, in order to reduce the risk of parasites developing resistance, as reported in a WHO Media Center News Release dated 19 Jan. 2006. Thus the use of artemisinin by itself as a monotherapy is explicitly discouraged by the World Health Organization because there are signs that malarial parasites are developing resistance to artemisinin alone.
Following is a list of patents that focus on the chemistry of artemisinin and its derivatives which include artesunate, dihydroArtemisinin and derivatives thereof used in antimalarials, mixed steroidal compounds, trioxane derivatives, and the like. U.S. Pat. No. 7,098,242 to ElSohly et al.; U.S. Pat. No. 7,071,226 to Singh et al.; U.S. Pat. No. 6,984,640 to Haynes et al.; U.S. Pat. No. 6,906,205 to Vennerstrom et al.; U.S. Pat. No. 6,906,098 to Solaja et al.; U.S. Pat. No. 6,750,356 to Bhakuni et al.; U.S. Pat. No. 6,737,438 to Singh et al.; U.S. Pat. No. 6,685,972 to Kumar et al.; U.S. Pat. No. 6,683,193 to Bhakuni et al.; U.S. Pat. No. 6,649,647 to Haynes et al.; U.S. RE38,117 to Zheng et al.; U.S. Pat. No. 6,461,603 to Bentley et al.; U.S. Pat. No. 6,346,631 to Jain et al.; U.S. Pat. No. 6,306,896 to Scheiwe; U.S. Pat. No. 6,160,004 to Posner et al.; U.S. Pat. No. 6,136,847 to Posner et al.; U.S. Pat. No. 6,127,405 to Kumar et al.; U.S. Pat. No. 5,856,351 to Zheng et al.; U.S. Pat. No. 5,225,562 to McChesney et al.; and U.S. Pat. No. 5,225,427 to Venugopalan et al.
U.S. patents covering various uses of berberine and derivatives thereof include U.S. Pat. Nos. 5,153,178; 4,980,344; 4,749,708; and 4,761,417 to Maroko.
Various patents provide the state of the art for synthetic drugs combined with natural herbal compounds, such as, artemisinin and berberine; the combination includes chemical and natural ingredients. A representative sample of patents and patent publications is provided below.
U.S. Pat. No. 8,026,209 to Gaillard et al. identifies antimalarials, such as artemisinin and berberine in the production of pharmaceutical compositions for targeting agents into and across the blood-barrier and other endothelial cell microvascular barriers.
U.S. Pat. No. 7,947,846 to Frincke discloses use of synthesized compounds to treat thrombocytopenia, neutropenia or delayed effects of radiation therapy and mentions that optional administration of additional therapeutic treatments could include analogs for viral infections or antimalarial agents such as artemisinin and berberine.
U.S. Pat. No. 7,935,839 to Frincke discloses sepsis treatment methods for cystic fibrosis, neutropenia that could include optionally administered additional therapeutic treatment from antimalarials, such as artemisinin and berberine.
U.S. Pat. No. 7,915,223 to Mor et al. discloses a novel class of antimicrobial polymeric agents and pharmaceutical compositions containing the same for treating medical conditions associated with pathological microorganisms and more. Mor et al. mentions artemisinin in combination with other drugs is preferred treatment for resistant strains of malaria.
U.S. Pat. No. 7,547,687 to Reading et al. discloses compounds used for treatment of cystic fibrosis, neutropenia that could include optionally administered additional therapeutic treatment from antimalarials, such as artemisinin and berberine.
U.S. Pat. No. 7,482,334 to Frincke et al. mentions therapeutic treatment methods using synthetic compounds and natural substances to ameliorate or treat cystic fibrosis, neutropenia and other conditions.
U.S. Pat. No. 5,413,928 to Weathers et al. references plants grown in vitro can provide a major source of specialty chemicals, which are plant secondary metabolites, such as artemisinin, a terpenoid found in the herb, Artemisia annua, to provide therapeutic treatment for malaria. Weathers et al. also reference that berberine, an alkaloid compound, can be extracted from the roots, rhizomes, stems and bark of a variety of Berberis plants, such as Oregon grape, Barberry, Tree Turmeric, Goldenseal, and others.
ActRx at website http.//actrxlimited.com/ (n.d.). retrieved October 2012 from ActRx: www.actrxlimited.com offers for sale a malaria-Dengue formular stating that all ingredients are rated GRAS (Generally Recognized As Safe); the ActRx adult formula has packet A, serving size two tables; artesnunate 50 mg and packet B Berberine alkaloid, service size two tablets 800 mg; and ActRx 80 mg injectable for malaria (no formula given). The product is packaged and offered in a manner that could lead to a consumer taking packet A and not packet B or vice versa and otherwise resulting in ineffective remediation of the disease or infection.
Thus, the prior art suggests that many chemical and natural compounds can be combined to provide therapeutic treatment for diseases, such as malaria. What is absent in the prior art is a formulation that combines, in one unit, such as a pill or tablet, two all-natural, herbal substances, namely, artemisinin and berberine, to deliver active therapeutic substances to relieve suffering from devastating infectious diseases, including, but not limited to malaria, yellow fever, dengue fever, dysentery, Lyme disease, babesiosis, progressive multifocal leukoencephalopathy, Helicobacter Pylori, and colitis.
There is also an obvious need for an ACT with a more effective and passively accurate delivery system, devoid of quinine, with all natural active ingredients, and in a form accessible and agreeable to children. The present invention fulfills this need as a treatment and as a preventive agent.